缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.002557022548272545152542002539722546430.27
215.182556792558402557600.05
单位质量响应值RSD%判断
16976.2016848.480.54数据可信
长期24月-供试品溶液-2023112521批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1132788-13278850.89851.601.8350.9051.601.83
2138300-13830053.01153.01
3133486-13348651.16651.17
4132688-13268850.86050.86
5137161-13716152.57552.57
6133222-13322251.06551.06
10min1171748-17174865.83266.871.3965.9266.961.39
2176228-17622867.54967.64
3177150-17715067.90367.99
4171733-17173365.82665.91
5176287-17628767.57267.66
6173575-17357566.53266.62
15min1188095-18809572.09873.421.0572.2973.621.05
2192039-19203973.61073.81
3193041-19304173.99474.19
4190531-19053173.03273.23
5193607-19360774.21174.41
6191978-19197873.58673.78
20min1196747-19674775.41476.941.1775.7377.261.17
2201174-20117477.11177.43
3203231-20323177.90078.22
4199525-19952576.47976.80
5202584-20258477.65277.98
6201087-20108777.07877.40
30min1205502-20550278.77080.301.2079.2180.741.20
2208578-20857879.94980.40
3211559-21155981.09281.54
4208309-20830979.84680.29
5212243-21224381.35481.81
6210735-21073580.77681.22
45min1213857-21385781.97383.351.1782.5483.941.17
2215696-21569682.67883.26
3220606-22060684.56085.15
4216682-21668283.05683.63
5219724-21972484.22284.81
6218207-21820783.64084.22
60min1218056-21805683.58284.781.1684.2985.501.16
2220391-22039184.47785.20
3224339-22433985.99086.72
4220850-22085084.65385.37
5224147-22414785.91786.65
6219318-21931884.06684.79
90min1222079-22207985.12486.541.1785.9787.411.17
2225737-22573786.52687.39
3229680-22968088.03888.91
4224205-22420585.93986.80
5227583-22758387.23488.11
6225395-22539586.39587.26
120min1225031-22503186.25687.731.7187.2588.741.69
2223213-22321385.55986.57
3232213-23221389.00990.03
4230656-23065688.41289.41
5232635-23263589.17090.19
6229551-22955187.98888.99
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1227240-22724087.10288.361.1188.2489.521.11
2227712-22771287.28388.43
3231658-23165888.79689.96
4231893-23189388.88690.03
5233768-23376889.60590.77
6230903-23090388.50789.66
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.674978402495721949547064950892494350049569440.27
216.694918829492496049218940.09
单位质量响应值RSD%判断
297357.17294900.780.59数据可信
长期24月-供试品溶液-2023112521批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1308738-3087385.8125.782.545.815.782.58
2312448-3124485.8825.88
3313247-3132475.8975.90
4297115-2971155.5935.59
5297718-2977185.6045.60
6313894-3138945.9095.91
10min1606605-60660511.41911.343.2011.4311.353.19
2609594-60959411.47511.49
3623817-62381711.74311.75
4572992-57299210.78610.80
5585725-58572511.02611.04
6615965-61596511.59511.61
15min1857024-85702416.13316.122.9416.1616.152.93
2863850-86385016.26216.29
3883060-88306016.62316.65
4819769-81976915.43215.46
5834182-83418215.70315.73
6879834-87983416.56216.59
20min11051942-105194219.80219.942.6819.8620.002.69
21068889-106888920.12120.18
31097681-109768120.66320.72
41020398-102039819.20819.26
51037814-103781419.53619.59
61079929-107992920.32920.39
30min11346334-134633425.34425.722.6125.4325.812.61
21377498-137749825.93126.02
31412516-141251626.59026.68
41314895-131489524.75224.84
51351707-135170725.44525.53
61395241-139524126.26526.36
45min11693663-169366331.88232.262.5532.0132.402.56
21712387-171238732.23532.37
31769677-176967733.31333.45
41655492-165549231.16431.29
51692165-169216531.85431.98
61760065-176006533.13233.27
60min11950857-195085736.72437.052.0336.9137.242.03
21979212-197921237.25837.44
32023467-202346738.09138.28
41906261-190626135.88436.06
51957945-195794536.85737.04
61991734-199173437.49337.68
90min12311615-231161543.51544.042.0943.7644.292.09
22340579-234057944.06044.31
32413737-241373745.43745.69
42284159-228415942.99843.24
52308609-230860943.45843.70
62379524-237952444.79345.05
120min12575291-257529148.47849.731.7848.8050.051.77
22623465-262346549.38549.71
32695942-269594250.75051.08
42679226-267922650.43550.74
52607631-260763149.08749.40
62669072-266907250.24450.57
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12729046-272904651.37352.121.4851.7752.521.48
22739851-273985151.57651.98
32823695-282369553.15553.57
42739870-273987051.57751.97
52766645-276664552.08152.48
62813929-281392952.97153.38
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.002585772585662584792586002584002585240.04
215.182590572592252591410.05
单位质量响应值RSD%判断
17234.9317071.210.68数据可信
长期24月-供试品溶液-2023112421批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1139865-13986552.85952.726.4452.8652.726.44
2148185-14818556.00456.00
3148538-14853856.13756.14
4142938-14293854.02154.02
5128273-12827348.47848.48
6129116-12911648.79748.80
10min1177104-17710466.93366.933.1967.0267.023.19
2183917-18391769.50869.60
3181893-18189368.74368.84
4178428-17842867.43367.52
5169220-16922063.95364.03
6172059-17205965.02665.11
15min1192242-19224272.65472.742.1972.8572.942.20
2196215-19621574.15674.36
3197409-19740974.60774.81
4193610-19361073.17173.37
5186529-18652970.49570.68
6188786-18878671.34871.54
20min1198204-19820474.90775.581.0475.2375.901.04
2201123-20112376.01076.34
3202518-20251876.53876.87
4200952-20095275.94676.27
5196920-19692074.42274.73
6200125-20012575.63375.94
30min1206967-20696778.21978.941.6378.6679.381.63
2212266-21226680.22280.68
3211807-21180780.04880.51
4208898-20889878.94979.40
5203179-20317976.78777.22
6210051-21005179.38579.82
45min1213838-21383880.81681.731.1181.3982.311.12
2217778-21777882.30582.90
3218404-21840482.54183.13
4216317-21631781.75382.34
5212851-21285180.44381.00
6218327-21832782.51283.08
60min1216135-21613581.68483.141.2582.3983.861.25
2222616-22261684.13384.86
3221296-22129683.63484.37
4220406-22040683.29884.02
5217114-21711482.05482.74
6222380-22238084.04484.75
90min1223095-22309584.31485.190.9485.1686.040.94
2226301-22630185.52686.40
3226907-22690785.75586.63
4223844-22384484.59785.45
5223873-22387384.60885.44
6228434-22843486.33287.18
120min1223958-22395884.64085.591.4485.6386.581.42
2225880-22588085.36786.38
3228054-22805486.18887.20
4223676-22367684.53485.53
5224973-22497385.02485.99
6232242-23224287.77188.76
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1226381-22638185.55686.480.7986.6887.620.79
2230073-23007386.95188.11
3230510-23051087.11788.27
4227626-22762686.02787.17
5227742-22774286.07187.18
6230619-23061987.15888.29
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.675020051502111150202795021672502117250208570.02
216.695028438503093050296840.04
单位质量响应值RSD%判断
301191.18301359.140.04数据可信
长期24月-供试品溶液-2023112421批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1321021-3210215.9405.946.745.945.946.74
2325345-3253456.0206.02
3335134-3351346.2016.20
4332251-3322516.1486.15
5334114-3341146.1826.18
6278336-2783365.1505.15
10min1614049-61404911.36211.075.1911.3711.085.19
2617687-61768711.42911.44
3618049-61804911.43611.45
4620981-62098111.49011.50
5568256-56825610.51410.52
6549598-54959810.16910.18
15min1856324-85632415.84415.374.4315.8715.404.45
2842797-84279715.59415.62
3856040-85604015.83915.87
4859131-85913115.89615.93
5798510-79851014.77514.80
6771670-77167014.27814.30
20min11062569-106256919.66019.234.5219.7219.284.54
21067490-106749019.75119.81
31037538-103753819.19719.25
41094493-109449320.25120.31
51011331-101133118.71218.76
6962738-96273817.81317.86
30min11339101-133910124.77724.282.9724.8624.372.97
21323608-132360824.49024.58
31340637-134063724.80524.89
41345287-134528724.89124.98
51260305-126030523.31923.40
61266149-126614923.42723.51
45min11656533-165653330.65030.332.3430.7830.452.35
21642899-164289930.39830.53
31663760-166376030.78430.91
41683015-168301531.14031.27
51607869-160786929.75029.87
61580033-158003329.23529.35
60min11904410-190441035.23734.871.9735.4235.051.98
21901184-190118435.17735.36
31879830-187983034.78234.96
41935247-193524735.80735.99
51852882-185288234.28334.46
61833429-183342933.92334.09
90min12269750-226975041.99641.581.7442.2441.821.74
22257934-225793441.77842.02
32273377-227337742.06342.30
42275547-227554742.10442.35
52230917-223091741.27841.51
62175159-217515940.24640.47
120min12539352-253935246.98546.431.0547.2946.731.05
22512355-251235546.48546.79
32534721-253472146.89947.21
42506258-250625846.37246.69
52493479-249347946.13646.43
62469377-246937745.69045.98
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12712393-271239350.18649.631.1350.5750.021.14
22692598-269259849.82050.21
32690759-269075949.78650.17
42706387-270638750.07550.47
52658136-265813649.18249.56
62634562-263456248.74649.11
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.002578802553242555192550812550402557690.47
215.182522392520242521320.07
单位质量响应值RSD%判断
17051.2716609.491.86数据可信
长期24月-供试品溶液-2023112421批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1140088-14008853.96747.4615.4853.9747.4615.48
299158-9915838.19938.20
3113023-11302343.54043.54
4107276-10727641.32641.33
5135137-13513752.05952.06
6144537-14453755.68155.68
10min1178518-17851868.77162.6911.5168.8662.7711.51
2141484-14148454.50454.57
3154610-15461059.56159.63
4143375-14337555.23355.30
5173311-17331166.76566.85
6185064-18506471.29371.39
15min1192361-19236174.10468.499.0774.3168.679.08
2159332-15933261.38061.53
3173054-17305466.66666.84
4160327-16032761.76361.92
5184631-18463171.12671.32
6197047-19704775.90976.12
20min1200711-20071177.32171.967.8177.6572.267.82
2171270-17127065.97966.24
3182418-18241870.27470.56
4170057-17005765.51265.78
5192228-19222874.05374.37
6204110-20411078.63078.97
30min1207746-20774680.03176.026.1480.4976.436.17
2183025-18302570.50770.87
3196668-19666875.76376.16
4183347-18334770.63171.00
5201437-20143777.60078.04
6211737-21173781.56882.04
45min1214488-21448882.62878.383.6283.2278.933.64
2195417-19541775.28175.77
3204368-20436878.72979.26
4197262-19726275.99276.48
5209244-20924480.60881.18
6200039-20003977.06277.67
60min1219048-21904884.38581.913.5985.1182.593.62
2203461-20346178.38078.99
3210905-21090581.24881.91
4205580-20558079.19679.81
5213625-21362582.29683.00
6223175-22317585.97586.71
90min1223343-22334386.03983.583.3886.9184.393.41
2210247-21024780.99481.73
3209293-20929380.62781.42
4213470-21347082.23682.99
5217976-21797683.97284.81
6227451-22745187.62288.50
120min1225276-22527686.78484.773.7187.8085.723.73
2205944-20594479.33780.21
3219294-21929484.47985.41
4218000-21800083.98184.87
5221736-22173685.42086.40
6229967-22996788.59189.61
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1226396-22639687.21583.159.2388.3784.249.14
2216924-21692483.56684.57
3176229-17622967.88968.96
4222890-22289085.86586.89
5222214-22221485.60486.73
6230392-23039288.75589.93
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.675005215500615050090625004616500390950057900.05
216.694927917492778149278490.01
单位质量响应值RSD%判断
300287.34295257.581.20数据可信
长期24月-供试品溶液-2023112421批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1350127-3501276.5555.3019.106.555.3019.05
2236951-2369514.4364.44
3256753-2567534.8074.81
4216822-2168224.0594.06
5304348-3043485.6985.70
6332460-3324606.2246.22
10min1658843-65884312.33510.5014.4012.3510.5114.43
2518425-5184259.7069.71
3517923-5179239.6969.70
4445264-4452648.3368.34
5592683-59268311.09611.11
6631193-63119311.81711.83
15min1902808-90280816.90214.7011.6916.9314.7211.70
2749187-74918714.02614.05
3731570-73157013.69613.72
4653870-65387012.24112.26
5809345-80934515.15215.18
6864155-86415516.17816.21
20min11093807-109380720.47818.1010.4420.5418.1510.46
2923655-92365517.29217.34
3905174-90517416.94616.99
4824331-82433115.43315.47
5998736-99873618.69818.75
61055238-105523819.75619.81
30min11381315-138131525.86023.508.0125.9523.588.03
21202405-120240522.51122.59
31202141-120214122.50622.58
41114517-111451720.86620.93
51285143-128514324.06024.14
61346474-134647425.20825.30
45min11714594-171459432.10029.195.7632.2429.315.77
21531114-153111428.66528.78
31489642-148964227.88828.00
41480164-148016427.71127.81
51613841-161384130.21430.34
61524862-152486228.54828.68
60min11956731-195673136.63334.494.8036.8234.664.82
21787696-178769633.46933.63
31747225-174722532.71132.87
41771002-177100233.15633.30
51856628-185662834.75934.93
61935197-193519736.23036.41
90min12304028-230402843.13541.194.2243.3941.424.24
22138231-213823140.03140.25
32061037-206103738.58638.80
42188827-218882740.97841.18
52215474-221547441.47741.71
62293624-229362442.94043.18
120min12560831-256083147.94346.184.1948.2746.484.20
22372663-237266344.42044.70
32312930-231293043.30243.58
42488719-248871946.59346.86
52494671-249467146.70447.01
62570595-257059548.12648.44
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12717842-271784250.88249.712.2951.2950.082.30
22595022-259502248.58348.94
32571559-257155948.14448.49
42697166-269716650.49550.84
52648533-264853349.58549.96
62699929-269992950.54750.94
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